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Frequently Asked Questions

TASIGNA

Ph+ CML is a cancer of the blood and bone marrow.

 

Blood is made up of 3 cells: white blood cells, red blood cells, and platelets. Leukemia [loo-key-mee-ah] is a disease that makes your white blood cells grow abnormally and out of control. As leukemia spreads, diseased cells take over the healthy ones. This can make you feel very sick.

 

Over time, leukemia cells can spread to the rest of your blood and other organs. When this happens, other cells in your body may stop working the way they should.

 

A main goal of treating Ph+ CML is to reduce the number of leukemia cells in your body. Doctors use medicine to lower the amount of leukemia in your blood.

 

It’s important to take an active role in your care. You can do this by taking your medicine the way your doctor tells you. You should also get regular tests to check how the medicine is working.

Ph+ CML happens when an abnormal gene called BCR-ABL1 produces an abnormal protein, also called BCR-ABL1. The BCR-ABL1 protein sends a signal that creates leukemic cells in the blood and bone marrow.

 

During in vitro studies, meaning studies that were conducted in test tubes, TASIGNA® (nilotinib) capsules was shown to bind to and stabilize the inactive formation of the ABL1 protein. This blocked the signal that leads to the production of leukemic cells.

 

Blocking the signal may reduce the amount of leukemic cells and allow healthy blood cells to grow.

 

The connection between TASIGNA in vitro data and its effectiveness has not been established.

PCR testing is an accurate way for doctors to measure how much BCR-ABL1 is in your body. PCR blood testing can find very small amounts of BCR-ABL1 that other tests cannot find.

 

PCR is a simple blood test, rather than a bone marrow test. However, doctors still must do bone marrow testing to diagnose Ph+ CML.

TASIGNA may cause side effects in some patients. Some of these side effects are serious, and some are more common.

 

  • Side effects may vary from patient to patient
  • Write down any side effects you are experiencing, and share this information with your doctor
  • Work closely with your doctor to best manage side effect

 

Serious TASIGNA side effects:

What is the most important information I should know about Tasigna?

Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.

Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG):

  • before starting Tasigna
  • 7 days after starting Tasigna
  • with any dose changes
  • regularly during Tasigna treatment

You may lower your chances for having QTc prolongation with Tasigna if you:

  • Take Tasigna on an empty stomach:
    • Avoid eating food for at least 2 hours before the dose is taken, and
    • Avoid eating food for at least 1 hour after the dose is taken.
  • Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking Tasigna. Food and grapefruit products increase the amount of Tasigna in your body.
  • Avoid taking other medicines or supplements with Tasigna that can also cause QTc prolongation.
  • Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
  • Do not take any other medicine while taking Tasigna unless your healthcare provider tells you it is okay to do so.
  • If you cannot swallow Tasigna capsules whole, you may open the Tasigna capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes). For more information, see "How should I take Tasigna?"

Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat while taking Tasigna. These can be symptoms of QTc prolongation.

 

Tasigna may cause serious side effects, including:

  • See "What is the most important information I should know about Tasigna?"
  • Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with Tasigna, but can also be severe. Your healthcare provider will check your blood counts regularly during treatment with Tasigna. Call your healthcare provider or get medical help right away if you develop any signs or symptoms of low blood counts including:
    • fever
    • chills or other signs of infection
    • unexplained bleeding or bruising
    • unexplained weakness
    • shortness of breath
  • Decreased blood flow to the leg, heart, or brain. People who have recently been diagnosed with Ph+ CML and take Tasigna may develop decreased blood flow to the leg, the heart, or brain. 
    Get medical help right away if you suddenly develop any of the following symptoms:
    • chest pain or discomfort
    • numbness or weakness
    • problems walking or speaking
    • leg pain
    • your leg feels cold
    • change in the skin color of your leg
  • Pancreas inflammation (pancreatitis). Tell your healthcare provider right away if you develop any symptoms of pancreatitis including sudden stomach area pain with nausea and vomiting.
  • Liver problems. Tasigna can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with Tasigna. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems including:
    • stomach area (abdominal) pain
    • yellow skin and eyes
    • dark-colored urine
  • Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:
    • kidney failure and the need for dialysis treatment
    • an abnormal heart beat

Your healthcare provider may do blood tests to check you for TLS.

  • Bleeding problems. Serious bleeding problems and death have happened during treatment with Tasigna. Tell your healthcare provider right away if you develop any signs and symptoms of bleeding during treatment with Tasigna.
  • Fluid retention. Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.
  • Abnormal growth or development in children. Effects on growth and development in children being treated for chronic phase CML is possible. The long term effects of prolonged treatment with Tasigna on growth and development in children are unknown.

The most common side effects of Tasigna in adults and children include:

  • nausea
  • rash
  • headache
  • tiredness
  • itching
  • vomiting
  • diarrhea
  • cough
  • constipation
  • muscle and joint pain
  • runny or stuffy nose, sneezing, sore throat
  • fever
  • night sweats

Side effects in adult patients attempting treatment free remission:

If you and your healthcare provider decide that you can stop taking Tasigna and try treatment free remission (TFR), you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:

  • muscle pain
  • arm and leg pain
  • joint pain
  • bone pain
  • spine pain

Tell your healthcare provider if you or your child have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Tasigna.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take TASIGNA on an empty stomach:

 

  • Avoid eating food for at least 2 hours before the dose is taken, and
  • Avoid eating food for at least 1 hour after the dose is taken

 

Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body.

 

Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation.

 

TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.

 

Do not take any other medicine while taking TASIGNA unless your healthcare provider tells you it is okay to do so.

 

If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes).

 

For more information, see “How should I take TASIGNA?”

 

Call your healthcare provider right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.

  • Take TASIGNA exactly as your health care provider tells you to take it. Do not change your dose or stop taking TASIGNA unless your health care provider tells you.
  • TASIGNA is a long-term treatment.
  • Your health care provider will tell you how many TASIGNA capsules to take and when to take them.
  • If your child takes Tasigna, your healthcare provider will change the dose as your child grows.
  • TASIGNA must be taken on an empty stomach.
    • Avoid eating food for at least 2 hours before the dose is taken, and
    • Avoid eating food for at least 1 hour after the dose is taken.
  • Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your health care provider.
  • If you cannot swallow TASIGNA capsules whole:
    • Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple).
      • Do not use more than 1 teaspoon of applesauce.
      • Only use applesauce. Do not sprinkle TASIGNA onto other foods.
    • Swallow the mixture right away (within 15 minutes).
  • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment.
  • If you miss a dose, just take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
  • If you take too much TASIGNA, call your health care provider or go to the nearest hospital emergency room right away. Symptoms may include vomiting and drowsiness.
  • During treatment with TASIGNA your health care provider will do tests to check for side effects and to see how well TASIGNA is working for you. The tests will check your:
    • heart
    • blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every 2 weeks for the first 2 months and then monthly.
    • electrolytes (potassium, magnesium)
    • pancreas and liver function
    • bone marrow samples

 

Your health care provider may change your dose. Your health care provider may have you stop TASIGNA for some time or lower your dose if you have side effects with it.

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